HeraBEAT User Manual Rev 7

Table of Contents

1. About HeraBEATTM Fetal Heart Rate Monitor

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2. Who should USE (Indications) or NOT USE (Contraindications) HeraBEATTM

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3. HeraBEAT

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kit includes 5

4. Safety Instructions 6 5. Ultrasound Transmission Gel

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6. HeraBEATTM Configuration & LED Indicators

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7. Charging HeraBEAT 10 TM

8. First Time Use 11 9. Measurement of the Fetal Heart Rate

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10. Care and Maintenance 17 11. Troubleshooting

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12. Smartphone General Security and Privacy

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13. HeraBEAT

Specification

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14. HeraBEATTM Device Label

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15. Warranty and Service 22 16. Appendices 25 17. Doctor Mode

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Read the entire user manual thoroughly prior to use. 3

About HeraBEAT™ Fetal Heart Rate Monitor

Congratulations on purchasing HeraBEATTM, your personal Fetal Heart Rate Monitor. For the first time ever, a safe, effective and easy-to-use Fetal Heart Rate monitor that delivers professional results within the comfort of your home. The HeraBEATTM unique software algorithm combines ultrasound Doppler used to measure the Fetal Heart Rate (FHR), an optical sensor to measure the Maternal Heart Rate (MHR) and distinguish between the two to prevent any confusion and a motion sensor used for motion detection and control. All these enable and ensure measurement accuracy. HeraBEATTM will assist and guide you to locate the optimal position for acquiring Fetal Heart Rate (FHR), measure the Fetal Heart Rate (FHR) and store the result in a simple and easy-to-access history file.

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Who should USE (Indications) or NOT USE (Contraindications) HeraBEAT™

Intended Use The HeraBEATTM hand-held fetal Doppler device is intended to be self-administered and used by pregnant women in the home environment for detecting Fetal Heart Rate (FHR). It is an over-the-counter (OTC) device.

Indications for Use The device is indicated for Fetal Heart Rate detection in pregnant women starting from the 12th week into pregnancy. The device is indicated for normal pregnancy.

Contra-Indications The HeraBEATTM device is NOT intended for: Fetal Heart Rate measurements in multiple pregnancy; Use during defibrillation, electro-surgery, applying HF surgical equipment, or magnetic resonance imaging (MRI);. Use during ECG measurements, on patients connected to external electrical stimulators, or with cardiac Pacemakers.

HeraBEAT™ kit includes

1. HeraBEATTM device 2. HeraBEATTM application (Free to download from the AppStore / Google Play.) 3. 2 Ultrasound Transmission Gel 4. Power Supply 5. Carry Case 6. User Manual

(fig. 1) HeraBEATTM device

(fig. 4) Power Supply

(fig. 2) HeraBEATTM application

(fig. 5) Carry Case

(fig. 3) 2 Ultrasound Transmission Gel

(fig. 6) User Manual

Check that the box includes all items. Do not use the device if it is damaged or an item is missing.

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Safety Instructions

Always adhere to all warnings and cautions. As with any electrical device, you must observe certain precautions to ensure your safety

Warnings

Warnings are directions which if not followed could cause fatal or severe injury to a user, patient or other person, or could lead to clinical misdiagnosis, and/or loss/damage of patient-related data. Use this device for its intended purpose only, as described in this user manual. HeraBEATTM measures the Fetal Heart Rate. For interpretation of measurement results, please consult your physician. The HeraBEATTM device is for personal use. Do not use the HeraBEATTM device on or near the eyes. Device must be charged only with the supplied power supply. (fig. 4) Do not charge the device under direct sun light. Use the device and its accessories only on intact skin. Do not leave the HeraBEATTM device unattended. Store the device and its accessories in secured place to prevent access and use of the device by unintended individuals and especially by children. Do not allow water or any liquids to enter the HeraBEATTM device or its charging connector. Do not use/store the device near any sources of water or liquids. Do not use the device if any liquids entered it or its charging connector. This device is not fire-resistant and cannot be used after exposure to fire or high temperatures. Although there are no confirmed biological effects on patients caused by exposures to ultrasound, the possibility

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exists that such biological effects may be identified in the future. Thus, use ultrasound in a prudent manner to provide you with a medical benefit. Do not drop the device. Do not use if cracked or broken. Do not touch the inner parts of the device. You must check that the device is intact before use. Discontinue use of the device with any sign of damage or loss of cover integrity. Should the device require service, it must be serviced only by authorized and trained personnel by HeraMED Ltd. to maintain safety, and reliability. Do not use the device close to explosive or highly flammable materials like alcohol, methanol, acetone, etc. Do not clean the device with alcoholic materials. Use device only with the supplied gel (fig. 3). Using ultrasound transmission gel that is not approved by HeraMED may reduce signal quality and can lead to absence of Fetal Heart Rate (FHR) measurement or inaccurate measurement results. The Ultrasound Transmission Gel is for external use only. (fig. 3) gel can be used on intact, unbroken skin. Prior to use, verify that the Ultrasound Transmission Gel (fig. 3) has not exceeded its expiry date (located on the tube). Gel is valid for 5 years from month of manufacture. For any Doppler examination, it is essential that an adequate supply of Ultrasound Transmission Gel is used to transmit the ultrasound energy from HeraBEATTM to the surface of the skin. Re-apply more gel if it starts to dry out or spread so thinly that an air gap occurs between the skin and the bottom of the device. Applying too much gel may impede the Maternal Heart Rate measurement. Incorrect placement of the device on the abdomen can lead to inaccurate measurement results. Follow the on-screen and voice instructions to locate the optimal position for Fetal Heart Rate (FHR) measurement.

Safety Instructions

Do not operate this device in temperatures lower than +5°C (41°F) or higher than +40°C (104°F), nor where humidity is lower than 5% or higher than 95% (non-condensing), or the device may fail or produce inaccurate measurement results. Long term storage outside of acceptable conditions may permanently reduce the battery capacity or lead to failure of the device and inaccurate measurement results. Wash hands before the measurement procedure to avoid contamination. Do not use the device if you are under 18 years of age. If you have any doubt about the fetal health status after using this device, please seek medical advice. Do not use the device in any case that your smartphone is damaged, or the app does not function properly.

Cautions Cautions are directions which if not followed could cause damage to the equipment on which the software of the medical device is installed and/or other equipment or goods, and/or cause environmental pollution. External interference can cause significant noise and impede the measurements. Ensure that the environment in which the device is operated is not subject to any sources of strong electromagnetic interference, such as radio transmitters, cordless telephones, portable and mobile RF communications equipment, etc. Keep far away from the interference sources no closer than 30 cm (12 inches) to any part of the device, including cables specified by the manufacturer. Do not dispose the device together with household garbage. Dispose only according to electrical device’s federal, state, and local regulations.

Notes Notes are intended to draw your attention and aid with the use of this medical device. Until pregnancy week 22 - if pulse is not found after 3 attempts of 30 min each, please go to be checked at your clinic / doctor. From pregnancy week 22 onwards - if pulse is not found after one 30 min attempt, please go to be checked at your clinic / doctor. For successful measurement please verify that gel is applied and device is gently pressed against the skin and held steady without any movement. If the displayed Fetal Heart Rate (FHR) value becomes briefly irregular, and then returns to a regular rhythm, do not reposition the HeraBEATTM device. The irregularity might be caused by fetal or maternal movement. There are several physiological conditions that may impair the ability to locate the Fetal Heart Rate: Detection of Fetal Heart Rate in early weeks of pregnancy can be challenging since the size of the fetus’ heart may be very small and might be missed. Excessive or prolonged fetal, maternal or device movements can degrade the ability to locate and measure the Fetal Heart Rate (FHR). If you are experiencing frequent fetal movements during the measurement, stop the measurement and try again once fetal movements have subsided. Placenta position: In cases of frontal placenta, it may take longer to detect the pulse and will require your patience during the search.

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Ultrasound Transmission Gel

Use device only with the supplied gel (fig. 3). Using ultrasound transmission gel that is not approved by HeraMED may reduce signal quality and can lead to absence of Fetal Heart Rate (FHR) measurement or inaccurate measurement results. The Ultrasound Transmission Gel (fig. 3) is for external use only. Gel can be used on intact, unbroken skin and on all patients in facilities where cross contamination is of minimal concern. Prior to use, verify that the Ultrasound Transmission Gel (fig. 3) has not exceeded its expiry date (located on the tube). The gel is valid for 5 years from month of manufacture. Contraindications The Ultrasound Transmission Gel (fig. 3) should not be used in: Any invasive procedures in which a device is passed through the tissue. Any procedure on or near broken skin, such as fresh surgical site or an open wound. Patients with an immunodeficiency or on immunosuppressive therapy. Any neonates or critically ill patients. Mucous membranes. Critically ill patients or patients in contact-, airborne- or droplet-transmission-based precautions. Warning and precautions Discard product if package is damaged or evidence of contamination is present. Do not use if known sensitivity to parabens exists. To avoid contamination, tip of the container should not come into contact with contaminating elements. Apply the gel to HeraBEATTM surface, and not directly on your skin. Storage conditions Store in a cool dry place. Store away from direct sunlight.

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HeraBEAT™ Configuration & LED Indicators

The HeraBEATTM measures the Fetal Heart Rate, processes the data and transmits the information wirelessly to the HeraBEATTM smartphone application (the HeraBEATTM App) using safe BLE communication channel. The HeraBEATTM App receives the digital information and displays the data to the user. The HeraBEATTM App guides the user step by step, to easily locate the Fetal Heart Rate (FHR), displays the Fetal Heart Rate values, stores the Fetal Heart Rate in the smartphone's memory, provides access to results history, and indicates the status of battery and connection with HeraBEATTM.

HeraBEATTM LED Indicators The device provides you with the following status indicators: Device turned OFF - light is OFF Device turned ON (waiting to be connected to the App) – constant white light Device is connected to the App – fast flashing of white light Device in measurement state – Ultrasound is ON– slow flashing of white light Device requires charging – device is flashing a white light 3 times and turns OFF Device is charging – orange light ON Device is fully charged – green light ON Review the device lights in the following two illustrations.

HeraBEAT™ configuration

Orange / Green charging lights

White light

HeraBEATTM Measurement START

GO

App Settings Menu

Tap on the Home Screen to start measurement session.

Tap to start Fetal Heart Rate Search in every new position

Tap on the Home Screen to access the in-app settings menu

Tutorial Tap to access the Tutorial.

Support END

Tap to end the Fetal Heart Rate measurement

Bluetooth Low Energy (BLE) connection

Tap for Support contact details

Tap to view the App version

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indicates that HeraBEA is connected to your smartphone. (BLE connected).

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indicates that HeraBEAT is NOT connected to your smartphone. (BLE NOT connected).

App Settings Menu Advanced Settings Tap to access the Advanced Settings. You can edit your Personal Information, Unpair Device, Sign In to Doctor Mode or Reset all App Private information. Note! Device Unpairing will separate the connection between the HeraBEAT device and the app and will allow to connect a new device to the app. Reset will permanently erase your personal information and all measurements history from the App. We recommend resetting when you want to use the device for a new pregnancy. Instructions for Doctor Mode can be found in section 17.

About

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App Home Screen

Change Language Tap to change the App language

Measurements History Measurement History Tap on the Home Screen to access the Measurements History. Recorded measurements will be displayed by pregnancy week.

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Charging HeraBEAT™

1. Use only supplied Power Supply for charging. (fig. 4) 2. Remove the charging connector cover. 3. Connect the Power Supply Cord to the HeraBEATTM device 4. Plug the Power Supply into an electrical outlet. 5. During charging orange light illuminates. Once fully charged, the orange light turns green. 6. Unplug the Power Supply from the electrical outlet and then disconnect its cord from the HeraBEATTM device. Before you turn ON and start using the device, fully charge it. When the HeraBEATTM device lights flash 3 times and the device turns OFF, it’s time to charge it. The device cannot be used during charging. Do not charge the device under direct sun light. Full charge time is approximately 4 hours. It is recommended not to over-charge the device. When device is not in frequent use, it is recommended to periodically charge it every 3 months.

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First Time Use

Note: The device must be operated using the smartphone application. Visit our website for a list of supported devices. Make sure you fully charge your HeraBEATTM prior to first use. Install HeraBEATTM App on your smartphone: Go to AppStore / Google-Play on your smartphone. Search for ‘HeraBEATTM ’ app in the AppStore/Google-Play and install it on your smartphone. When the App starts for the first time, the Tutorial will guide you how to use the device. Fill in your personal information: Last menstrual period date, Maternal date of birth & Number of previous pregnancies. HeraBEATTM will optimize the guided search based on the gestational age (12-18, 19-24, 25-42). The search will recommend the lower abdomen area for pregnancy weeks 12 to 18. All measurement results are recorded according to your pregnancy week. Please make sure that you fill in your personal information accurately! Turn HeraBEATTM ON by giving it a little shake, or by unplugging it from the power supply (fig. 4). A White light will quickly turn on. Note: The device will turn itself off automatically 2 minutes after it is not in use and disconnected from the App.

The app will automatically search for and attempt to connect to a HeraBEATTM device. When a device is found, the app will ask if the HeraBEATTM device is flashing a white light for verification. Tap ‘YES’. The app will connect to the device. This is only for first use, next time the app finds the same unique HeraBEATTM device, it will automatically connect to it. If the connection to HeraBEATTM has not been established, verify that the HeraBEATTM device is turned ON (a constant white light will show), then stop the app and re-launch it.

To assist you with the Fetal Heart Rate Search, during the first 3 measurement sessions, the search will be guided by the app. Starting from the 4th measurement you can select the Guided Search or the Manual Search. In Guided search the app will instruct you where to position the device on your abdomen. In manual search, you can select where to position the device based on your experience. You can return to the Tutorial anytime from the App settings menu.

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Measurement of the Fetal Heart Rate

1. Before starting a Measurement session Before you begin a search, please make sure you have available with you: HeraBEATTM (fig. 1), your smartphone (fig. 2), the supplied ultrasound transmission gel tube (fig. 3) and a clean paper tissue/ towel. It is recommended that you find a comfortable position before starting any measurement session. Lean back on a pillow in bed or on a couch.

2.2 HeraBEATTM Smartphone preparation

To perform measurement with no disturbances, it is recommended to switch your smartphone to Airplane Mode (Airplane Mode ON). Otherwise, any incoming cellular communication will stop the measurement.

2. Measurement preparations 2.1 HeraBEATTM preparation Turn the HeraBEAT device ON by giving it a little shake, or by unplugging it from the power supply (fig. 4). A White light will quickly turn on. Note: The device will turn itself off automatically after 2 minutes if not used and disconnected from the App. TM

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The HeraBEATTM device communicates with your smartphone via Bluetooth Low Energy, therefore please ensure that your smartphone’s Bluetooth is turned ON (Bluetooth ON).

Measurement of the Fetal Heart Rate

2.3 HeraBEATTM APP preparation Start the HeraBEATTM App. Wait for HeraBEATTM to connect. The App will automatically create a Bluetooth connection which will be indicated on the screen. Once connection with HeraBEATTM is obtained, it will rapidly flash a white light. Please verify the device is turned ON, otherwise turn it on by giving it a little shake.

3. Applying the Ultrasound Transmission Gel: 3.1

Apply a drop of supplied ultrasound transmission gel (fig. 3), about the size of your little finger, to the bottom surface of the HeraBEATTM device.

3.2 3.3 3.4

Place HeraBEATTM bottom side on your abdomen area and position over the bellybutton. Hold the device in the palm of your hand and press it gently against your abdomen. Perform a circular motion to ensure a thin and even layer of gel between HeraBEATTM and the skin. Re-position the device over the bellybutton and make sure the bottom surface is fully touching your skin during the entire measurement.

Bottom Surface

4. Fetal Heart Rate Search 4.1 Tap the ‘START’ button. HeraBEATTM will guide you through several search positions, while it is searching for the Fetal Heart Rate. For each search position, tap the ‘GO’ button and wait while keeping the device steady. HeraBEATTM will optimize the guided search based on your pregnancy week.

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Measurement of the Fetal Heart Rate

4.2 Follow the on-screen instructions, while maintaining the following: 1. There is always a thin and even layer of gel between HeraBEATTM and your skin. Note that the gel will dry after several minutes. Add gel as required to maintain a thin, moist layer. 2. Apply a small amount of pressure on HeraBEATTM against your skin. Verify full contact during the entire measurement.

3. Hold HeraBEATTM steady while it is searching and measuring.

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4.3 During the search Note: The measurement is sensitive to noises which occur due to talking, eating, heavy breathing or moving. Please refrain from these actions during the measurement. Abdominal activity or fetal movements detected may prolong the search duration, you may be requested to wait in your current position to allow the device to locate the fetal heart rate. At the bottom of the screen a running graph will indicate device activity. Next to the graph, a level bar displays the signal level. If the Fetal Heart Rate is not detected at a certain position, you will be asked to move HeraBEATTM to the next position (the new position will be displayed on the screen). The distance between search positions is about 2 fingers wide. The app will remind you to add more gel, if necessary, every 5 search positions.

Measurement of the Fetal Heart Rate

5. Fetal Heart Rate Measurement The HeraBEATTM app will inform you when the Fetal Heart Rate is detected. The app will then move to the measuring screen. Hold steady while HeraBEATTM is measuring the Fetal Heart Rate. The App will present and record the measurement. The measured Fetal Heart Rate is displayed in the center of the screen and a Fetal Heart Rate sound is played. Results are presented in Beats Per Minute (BPM). The white depleting ring around the Fetal Heart Rate value represents the duration of successful measurement, limited to five minutes. The time duration for the measurement session is displayed at the top of this screen. Rotating the screen to landscape will display a realtime graph of the measured Fetal Heart Rate. If fetal heart rate tracking is lost during measurement, the App will display ‘Wait’ instead of the fetal heart rate value. Keep the device steady until the fetal heart rate is located again. If the fetal heart rate is not located again after 20 consecutive seconds, the App will move back to the Search Screen in order to guide you to locate the fetal heart rate.

6. END Measurement Session Once the fetal heart rate has been recorded, the app will offer you to end the measurement. You may also choose to continue, in which case the measurement will complete a 5 minute session. You can always choose to end the measurement at any time by tapping the ‘END’ button, or by closing the App or by Switching to another App. The measurement will end upon an incoming call. You can start the measurement again once you return to use the app. ‘Airplane Mode ON’ will allow you to perform the measurement with no interruptions. The HeraBEATTM device switches off automatically if no operation is performed for 2 minutes and the device is not connected to the smartphone. Turn off the Airplane Mode on the smartphone.

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Measurement of the Fetal Heart Rate

7. Measurement Results Once the measurement has finished, the measurement results screen is shown. The measurement results screen includes: A test name at the top including pregnancy week, date and time An average Fetal Heart Rate A graph presenting the measured Fetal Heart Rate over time. Measurement duration (total time from search start to measurement end). Rotate smartphone screen to landscape to view the entire graph in full screen. A dashed vertical line within the measurement results screen indicate a loss and regain of the Fetal Heart Rate during the measurement. Use the Share key to share the measurement results. Make sure to switch OFF airplane mode in order to share measurements.

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8. Measurements History All recorded measurements are kept and organized by pregnancy weeks in the history screen. Tap any week to see its measurements shown below. Tap a specific measurement to see its results screen.

Care and Maintenance Cleaning

Before cleaning HeraBEATTM , ensure that it is unplugged from the power supply (fig. 4). At the end of each session, clean the device with a soft dry cloth or tissue, making sure to remove all of the ultrasound gel. After cleaning, verify the product is intact. Discontinue use with any sign of damage or loss of cover integrity. Once clean and dry, store the device in its carry case (fig. 5) and locate it with its accessories in a safe cool an dry place, away from direct sunlight. Follow temperature and humidity guidelines as specified in this Instructions for Use.

Disinfection

The device is intended for personal use. If transferred between patients, it must be disinfected. In any case of need for disinfection, follow the instructions below: 1. Before cleaning or disinfection, ensure that it is unplugged from the power supply. 2. Use a soft cloth, mildly moistured with soap or detergent solution, to clean the device until it is visually clean. 3. Use a soft cloth, mildly moistured with water to remove soap or detergent solution residuals. 4. Use a soft, dry cloth to dry the device. 5. Use a soft cloth, moistened with 70% medical grade alcohol, to disinfect the device for at least 1 minute. 6. Use a soft, dry cloth to dry the device. 7. Verify the device is intact. Discontinue use with any sign of damage or loss of cover integrity. 8. Once clean and dry, store the device with its accessories in a safe cool and dry place, away from direct sunlight.

Care and Maintenance Warning: Never submerge the device in liquids. Do not allow any liquid to enter the device and especially the charging connector. Do not use strong solvent, for example, acetone. Never use an abrasive such as steel wool or metal polish. The device is not intended to be sterilized.

Troubleshooting Problem: The HeraBEATTM device is not connected or the app and device frequently disconnect. Details: The ‘No connection’ message or icon is displayed. Solution: 1. Verify that HeraBEATTM is located within 3 meters from your smartphone. 2. Ensure that Bluetooth on the smartphone is turned ON. 3. Ensure that HeraBEATTM is ON. Turn HeraBEATTM ON by giving it a little shake, or by plugging and unplugging it from the power supply after charging (fig. 4). The white light ring on the top part of the device will quickly turn on. Note: The device will turn itself off automatically after 2 minutes if not in use and disconnected from the App. 4. Close the HeraBEATTM app and restart it.

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Troubleshooting

Problem: The device failed to detect the Fetal Heart Rate, or measured rate is inconsistent. Details: The device failed to detect the Fetal Heart Rate at all recommended locations. Solution: 1. Measurement is fully effective when: a. There is always a thin and even layer of gel between HeraBEATTM and your skin. Note that the gel might dry after several minutes. Add gel as required to maintain a thin, moist layer. b. Apply a small amount of pressure on HeraBEATTM against your skin. Verify full contact during the entire measurement. c. Hold HeraBEATTM steady while it is searching and measuring. d. Carefully follow the step-by-step guidance as the App suggests. 2. Excessive or prolonged fetal, maternal or device movements can degrade the ability to locate and measure the Fetal Heart Rate (FHR). If you’re experiencing frequent fetal movements during the measurement, stop the measurement and try again once fetal movements have stopped. 3. Detection of Fetal Heart Rate in early weeks of pregnancy can be challenging in some cases. The size of the fetus’ heart can be very small and it might be missed. 4. It is recommended to perform measurements at least 1 hour after major meals as these may cause abdominal noises that may interrupt the measurement. 5. Consult with your physician.

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Problem: The device does not turn ON or the device’s battery is low. Details: The ‘low battery’ message is displayed. Solution: 1. Stop the current test using END button. 2. Charge the device. Note: If the battery does not charge or does not hold a charge, please contact Service. ([email protected]) Problem: Device is flashing a white light 3 times and turns OFF. Details: Device may require charging Solution: 1. Charge the device. 2. If error persists, contact service. ([email protected]) Problem: App crashes. Details: A general error may have occurred. Solution: 1. Close and restart the app. 2. If error persists, restart the smartphone. 3. If error persists, contact service. ([email protected]) Problem: Charge light is flashing both orange and green lights. Details: An error with the charge circuit has occurred. This may be due to a depleted battery. Solution: 1. Contact service. ([email protected])

Smartphone General Security and Privacy

The product software installed and the information stored on the smartphone should be protected from unauthorized access and from external threats. We recommend the following security measures: The physical protection of the device: Do not leave the device and your smartphone unattended; Do not allow others to use your devices. Use only official Operating System versions. Do not jailbreak or root smartphones; Avoid installing untrusted apps on the smartphone; Download apps only from trusted sources such as the Google Play store. Minimize installation of unnecessary apps; Install latest software versions and apply security patches on the smartphone; Beware of wireless connections: avoid connection to untrusted services, and disable auto-connect to Wi-Fi signals; Avoid making your smartphone avaible in networking (Bluetooth or Wi-Fi); Hide the network SSID (network name); Avoid use of untrusted information services, web services and web apps (do not follow links sent in suspicious emails or text messages); Access controls: use of screen lock and secured unlock option is recommended (numeric PIN code, password or finger print); Security software including malware protection is recommended; Use official ;antitheft services;

Backup smartphone data. Log out of any website that you conduct financial transactions on. Special care should be taken when using smartphones in public places and other unprotected areas. Protection should be in place to avoid the unauthorized access to or disclosure of the information stored and processed by the smartphone, e.g. using cryptographic techniques and enforcing use of secret authentication information. The smartphone should also be physically protected against theft especially when left, for example, in cars and other forms of transportation, hotel rooms, conference centers and meeting places. Devices carrying important, sensitive or personal health information should not be left unattended and, where possible, should be physically locked away, or special locks should be used to secure the devices. Use of a home Wi-Fi system with secured access (via Wi-Fi WPA2 standard) is strongly recommended. The practical implementation of technical security elements varies by module of smartphone and version of operating system and security software used, and may employ several technologies, including virus scanning software, authentication technologies, etc. The information recorded by the app is stored on your smartphone. If someone gains access to your smartphone, they can be exposed to this information. Sharing the information via the app, is at your own risk and discretion.

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HeraBEAT™ Specification

Safety Complies with

IEC/EN 60601-1, 60601-1-2, 60601-1-11, 60601-2-37

Classification Anti-electric Shock Type Internally powered equipment Anti-electric Shock Degree Type BF equipment Degree of Protection against Harmful Ingress of Water IP22 Protection against falling drops of water when unit is tilted 15o Physical Characteristics Device size Device weight

88 x 37 mm, 3.5 x 1.5 inch (Diameter × Height, ±2mm) Approximately 130g (.29 lb.)

Operating Environment Temperature Humidity

From 5°C to 40°C (41°F up to 104°F) From 5% up to 90% RH (non-condensing)

Storage/Transport Environment Temperature From -20°C to +60°C (-4°F up to 140°F) Humidity From 5% up to 95% (non-condensing) Light intensity No direct sun light FHR Performance Pregnancy Week FHR Measuring Range; Accuracy; Resolution

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12 to 42 50 to 240 BPM; ±2BPM; 1 BPM

Auto Acquisition stop

5 minutes of successful measurement

Recommended Ultrasound Water soluble hypoallergenic Transmission Gel ultrasonic gel Power consumption

<2W

Rechargeable Li-ion Battery Nominal Capacity 3.7VDC, 1250 mAh Continuous Work Time 4 hours (with a new battery) Power Input 5 V DC, >0.3A Charge Time 4 hours Ultrasound Nominal Frequency 2 MHz ±10% Ultrasonic Output Power (P) 70 mW Peak acoustic pressure (pr, at Z MI) 0.022 MPa Ultrasonic Output Intensity (Isat ) <20 mW/cm2 Mechanical Index (MI) 0.022 Thermal index (TIS; TIB) 0.26; 0.7 Measurement Mode Continuous Wave Ultrasound Doppler Effective Radiating Area of Transducer 4.9±0.5 cm2

HeraBEAT™ Device Label

Manufacturer

Below are the HeraBEATTM label and symbols used on the device and packaging. When contacting Service, have readily available the device Serial Number colored pink.

Date of Manufacture Serial Number

IP22

Ingress Protection Caution - Consult Accompanying Documents Type BF applied part (Degree and type of protection against electric shock) Waste of Electrical and Electronic Equipment (WEEE) compliance symbol Caution - Refer to instruction manual/booklet Bluetooth

2797

BSI CE mark Caution: Federal law restricts this device to sale by or on the order of a physician.

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